JANUMET or JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Your doctor will determine whether JANUMET or JANUMET XR is right for you.

JANUMET or JANUMET XR should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUMET or JANUMET XR.

This site has information about type 2 diabetes and how JANUMET XR and JANUMET work to help lower blood sugar. You will also find tools to track your progress and other resources to help you ask the questions that are important to you at your next doctor appointment.

Also, check out Steps to Diabetes Goals, a program that provides information on type 2 diabetes, including tips and tools that you may find useful.

Talk to your doctor to see whether JANUMET® XR (sitagliptin and metformin HCl extended-release) or JANUMET® (sitagliptin and metformin HCl) could be right for you.

JANUMET or JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Your doctor will determine whether JANUMET or JANUMET XR is right for you.

JANUMET or JANUMET XR should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUMET or JANUMET XR.

Selected Risk Information About JANUMET and JANUMET XR

Metformin, one of the ingredients in JANUMET and JANUMET XR, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking JANUMET or JANUMET XR and call your doctor right away if you get any of the following symptoms of lactic acidosis: you feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual onScreenDetectsleepiness or sleep longer than usual; have sudden stomach or intestinal problems with nausea and vomiting or diarrhea; feel cold, especially in your arms and legs; feel dizzy or lightheaded; or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis if you have kidney problems, liver problems, or congestive heart failure that requires treatment with medicines; if you drink alcohol very often, drink a lot of alcohol in a short period of time, or get dehydrated (lose large amounts of body fluids); if you have certain x-ray tests with dyes or contrast agents that are injected into your body; or if you have surgery, a heart attack, severe infection, or stroke.

Pancreatitis is another serious side effect that can happen in people taking JANUMET or JANUMET XR. Pancreatitis may be severe and lead to death. Before you start taking JANUMET or JANUMET XR, tell your doctor if you've ever had pancreatitis. Stop taking JANUMET or JANUMET XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Do not take JANUMET or JANUMET XR if you are allergic to any of the ingredients in JANUMET or JANUMET XR. Allergic reactions, which may be serious, including rash; hives; or swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking JANUMET or JANUMET XR and call your doctor right away.

Do not take JANUMET or JANUMET XR if your kidneys are not working properly. Your doctor will do blood tests before and during your treatment to see how well your kidneys are working.

Tell your doctor if you are going to get an injection of dye or contrast agent for an x-ray procedure; JANUMET or JANUMET XR will need to be stopped for a short time.

If you take JANUMET or JANUMET XR with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea
or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery.

Kidney problems, sometimes requiring dialysis, have been reported.

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET and JANUMET XR, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Common side effects when taking JANUMET or JANUMET XR include stuffy or runny nose and sore throat, upper respiratory tract infection, diarrhea, nausea and vomiting, gas, upset stomach, indigestion, weakness, headache, and low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for JANUMET® (sitagliptin and metformin HCl) tablets or JANUMET®XR (sitagliptin and metformin HCl extended-release) tablets, including the information about lactic acidosis, and discuss it with your doctor. The physician Prescribing Information for JANUMET or JANUMET XR also is available.

This site is intended only for residents of the United States, its territories, and Puerto Rico.
DIAB-1035114-0035 02/2016

JANUMET or JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Your doctor will determine whether JANUMET or JANUMET XR is right for you.

JANUMET or JANUMET XR should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUMET or JANUMET XR.

Selected Risk Information About JANUMET and JANUMET XR

Metformin, one of the ingredients in JANUMET and JANUMET XR, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking

You have a higher chance of getting lactic acidosis if you have kidney problems, liver problems, or congestive heart failure that requires treatment with medicines; if you drink alcohol very often, drink a lot of alcohol in a short period of time, or get dehydrated (lose large amounts of body fluids); if you have certain x-ray tests with dyes or contrast agents that are injected into your body; or if you have surgery, a heart attack, severe infection, or stroke.

Pancreatitis is another serious side effect that can happen in people taking JANUMET or JANUMET XR. Pancreatitis may be severe and lead to death. Before you start taking JANUMET or JANUMET XR, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUMET or JANUMET XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Before prescribing JANUMET® (sitagliptin and metformin HCl) tablets, please read the accompanying Prescribing Information, including the Boxed Warning about lactic acidosis. The Medication Guide also is available.

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